Trial Outcomes & Findings for Studying the Influence of Exposure to Maternal Voice on Oral Feeding Volumes in Preterm Infants (NCT NCT05181020)

Last Updated: 2026-06-05

Results Overview

Effect of maternal voice immediately prior to feeding on oral feed proportions in preterm infants. Proportion of oral feeds is defined as the volume of oral intake divided by the prescribed volume for the feeding for each feeding session. The change from baseline to post intervention and follow- up is reported.

Recruitment status

COMPLETED

Study phase

Target enrollment

25 participants

Primary outcome timeframe

Oral feeding proportions were collected for baseline feed 3 hr prior to the intervention, for post intervention feed immediately after the intervention and for follow-up feed 3 hr after the intervention.

Results posted on

2026-06-05

Participant Flow

Subjects enrolled in Open bay NICU between 6/1/2020 and 9/30/2020.

Only infants were considered enrolled in the study

Participant milestones

Participant milestones
Measure	Maternal Voice Exposure Infants enrolled will be exposed to maternal voice for 20 min immediately prior to being offered oral feedings. This exposure will be conducted 2 times a day until infant starts taking all enteral feeds orally. Maternal Voice Exposure: Main objective of this study is to determine if it is possible to expose preterm infant in a systematic manner to mother's voices before their feeds and to determine if this exposure results in an increase in their oral intake.
Overall Study STARTED	25
Overall Study COMPLETED	25
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Studying the Influence of Exposure to Maternal Voice on Oral Feeding Volumes in Preterm Infants

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Maternal Voice Exposure n=25 Participants Infants enrolled will be exposed to maternal voice for 20 min immediately prior to being offered oral feedings. This exposure will be conducted 2 times a day until infant starts taking all enteral feeds orally. Maternal Voice Exposure: Main objective of this study is to determine if it is possible to expose preterm infant in a systematic manner to mother's voices before their feeds and to determine if this exposure results in an increase in their oral intake.
Age, Continuous	32 weeks STANDARD_DEVIATION 2 • n=20 Participants
Sex: Female, Male Female	11 Participants n=20 Participants
Sex: Female, Male Male	14 Participants n=20 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	4 Participants n=20 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	21 Participants n=20 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=20 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=20 Participants
Race (NIH/OMB) Asian	0 Participants n=20 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=20 Participants
Race (NIH/OMB) Black or African American	10 Participants n=20 Participants
Race (NIH/OMB) White	10 Participants n=20 Participants
Race (NIH/OMB) More than one race	0 Participants n=20 Participants
Race (NIH/OMB) Unknown or Not Reported	5 Participants n=20 Participants
Region of Enrollment United States	25 participants n=20 Participants

PRIMARY outcome

Timeframe: Oral feeding proportions were collected for baseline feed 3 hr prior to the intervention, for post intervention feed immediately after the intervention and for follow-up feed 3 hr after the intervention.

Population: The difference in proportion of feeds from baseline feeds to Intervention feeds and Follow-up feeds was calculated.

Outcome measures

Outcome measures
Measure	Maternal Voice Exposure n=25 Participants Infants enrolled will be exposed to maternal voice for 20 min immediately prior to being offered oral feedings. This exposure will be conducted 2 times a day until infant starts taking all enteral feeds orally. Maternal Voice Exposure: Main objective of this study is to determine if it is possible to expose preterm infant in a systematic manner to mother's voice before their feeds and to determine if this exposure results in an increase in their oral intake.
Proportion of Oral Feedings Difference in proportion of feeds from Baseline to Intervention feeds	0.0408 proportion of feeds Standard Deviation 0.363
Proportion of Oral Feedings Difference in proportion of feeds from Baseline to Follow-up feeds	0.0187 proportion of feeds Standard Deviation 0.338

Adverse Events

Maternal Voice Exposure

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Shabnam Lainwala, MD Neonatologist

Connecticut Children's Medical Center

Phone: 8605458950

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place